ID

31255

Descripción

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip; ODM derived from: https://clinicaltrials.gov/show/NCT00541489

Link

https://clinicaltrials.gov/show/NCT00541489

Palabras clave

Versiones (1)
  1. 3/8/18 3/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00541489

Inglés

Eligibility Osteoarthritis NCT00541489

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women (40 or older) with a diagnosis of primary oa of the hip
Descripción

Age | Primary osteoarthritis of hip

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2893909
must be a current chronic user of nsaids or acetaminophen
Descripción

NSAIDs chronic | Acetaminophen chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0205191
must discontinue all analgesic therapy at screening
Descripción

Analgesic therapy To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C1272691
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hypertension or diabetes
Descripción

Uncontrolled hypertension | Diabetic - poor control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421258
hepatic or renal impairment
Descripción

Hepatic impairment | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
current or expected use of anticoagulant
Descripción

Anticoagulants | Anticoagulants Expected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1517001
clinically relevant abnormal ecg
Descripción

ECG abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
a history of alcohol or drug abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
diagnosis of gastric or duodenal ulceration and/or history of significant gastro‑duodenal bleeding, within the last 6 months
Descripción

Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038358
UMLS CUI [2]
C0013295
UMLS CUI [3]
C1096494
current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
Descripción

Disease Interferes with Evaluation | Arthritis Interferes with Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0220825
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0220825
candidates for imminent joint replacement
Descripción

Joint replacement Anticipated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1442800
UMLS CUI [1,2]
C3840775
participation within 30 days prior to screening in another investigational study
Descripción

Study Subject Participation Status | Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Osteoarthritis NCT00541489

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Primary osteoarthritis of hip
Item
men and women (40 or older) with a diagnosis of primary oa of the hip
boolean
C0001779 (UMLS CUI [1])
C2893909 (UMLS CUI [2])
NSAIDs chronic | Acetaminophen chronic
Item
must be a current chronic user of nsaids or acetaminophen
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Analgesic therapy To be stopped
Item
must discontinue all analgesic therapy at screening
boolean
C0412784 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension | Diabetic - poor control
Item
uncontrolled hypertension or diabetes
boolean
C1868885 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
Hepatic impairment | Renal Insufficiency
Item
hepatic or renal impairment
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Anticoagulants | Anticoagulants Expected
Item
current or expected use of anticoagulant
boolean
C0003280 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
ECG abnormal
Item
clinically relevant abnormal ecg
boolean
C0522055 (UMLS CUI [1])
Substance Use Disorders
Item
a history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage
Item
diagnosis of gastric or duodenal ulceration and/or history of significant gastro‑duodenal bleeding, within the last 6 months
boolean
C0038358 (UMLS CUI [1])
C0013295 (UMLS CUI [2])
C1096494 (UMLS CUI [3])
Disease Interferes with Evaluation | Arthritis Interferes with Evaluation
Item
current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0003864 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Joint replacement Anticipated
Item
candidates for imminent joint replacement
boolean
C1442800 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial
Item
participation within 30 days prior to screening in another investigational study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Volver a la parte superior de la página 

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